Baclofen

Product NDC
50090-1801
11-digit product format
500901801
Labeler code
50090
Product ID
50090-1801_7d0554ff-01b6-4828-b936-523e94271762
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077068
Marketing category
ANDA
Marketing start
2005-08-30
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
20 mg/1
Pharmacologic classes
GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1801-12023-01-30C16284748780-1f386c649-a919-0266-e053-dadaa90a7c1aBaclofen Tablets, USP
50090-1801-22023-01-30C16284748780-1f386c649-a919-0266-e053-dadaa90a7c1aBaclofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1801-1Baclofen60 in 1 BOTTLETABLET608
50090-1801-2Baclofen30 in 1 BOTTLETABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1801-1EA - Each50090-1801de1b489f-1d67-4323-bd95-009a5aa99dea12018-10-11
50090-1801-2EA - Each50090-1801335e3fad-4ed3-4071-806a-ed841dcf877b12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1801BACLOFEN TABLET [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20200122_1f566955-2942-4d9a-a030-fcce4c47fd25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197392baclofen 20 MG Oral TabletPSN1f566955-2942-4d9a-a030-fcce4c47fd258
197392baclofen 20 MG Oral TabletSCD1f566955-2942-4d9a-a030-fcce4c47fd258

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1801-15009018010160 TABLET in 1 BOTTLE (50090-1801-1) 60 tablet2015-04-300000-00-00NoNoCurrent
50090-1801-25009018010230 TABLET in 1 BOTTLE (50090-1801-2) 30 tablet2015-04-300000-00-00NoNoCurrent